Diagnostica Stago recalls STA Compact Max analyzers with reference numbers 58602/58612 due to a firmware bug causing inconsistent coagulation test results. Affected units may show intermittent shortened coagulation times and error 13.
An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the analyzer (error 13).
Diagnostica St:ago is recalling its STA Compact Max clinical analyzers with reference numbers 58602 and 58612. The recall is due to a firmware bug that can cause inconsistent coagulation test results, potentially leading to inaccurate blood test outcomes.
The firmware bug causes the analyzer to occasionally report shortened coagulation times and trigger error 13. This can lead to inaccurate blood test results, which might affect medical decisions about patient treatment.
Healthcare facilities using the STA Compact Max analyzers with reference numbers 58602 or 58612 are likely affected. Laboratory staff and medical professionals who perform blood tests with these devices are at risk of receiving inaccurate coagulation results.
Check for reference numbers 58602 or 58612 on the device. The device also has UDI-DI: 036074505898 and serial numbers like 5061471, 5061474, 0000007405, CF70015885, or CF70015886.
Identify if your STA Compact Max analyzer has reference numbers 58602 or 58612.
An internal investigation found a firmware bug causing intermittent shortened coagulation times and error 13 in the analyzer.
The recall record does not specify a remedy, so no action is required beyond checking if your device has the reference numbers.
Check for reference numbers 58602 or 58612, UDI-DI: 036074505898, or serial numbers like 5061471, 5061474, 0000007405, CF70015885, or CF70015886.
We’ve drafted a message you can send Stago to request your refund or repair — edit it as you like.
Subject: Recall Z-1577-2023 — Stago Stago Hello, I own a Stago that is covered by recall Z-1577-2023 from Stago. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
